An interventional study of Ex situ hypothermic oxygenated machine preservation in Kidney Transplant and DCD Kidney, sponsored by Karolinska University Hospital. Not yet recruiting at 3 sites in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Karolinska University Hospital · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to learn if the combination of Normothermic Regional Perfusion (NRP) at the time of organ procurement with ex situ Hypothermic Oxygenated Perfusion (HMPO2) of kidneys recovered from donors after circulatory death (DCD) is superior to NRP alone. The researchers will learn if the combined use of these technologies provides a benefit in terms of kidney transplant outcomes. The researchers will also learn about the patient quality of life after these transplants and if the use of these technologies is cost efficient. The main questions it aims to answer are:
Participants will:
The trial is designed as a randomised, controlled, multicentre superiority trial with the primary endpoint of eGFR at one year after kidney transplant. The trial will be carried out in the four academic hospitals with renal transplant programs in Sweden: Stockholm, Gothenburg, Malmo and Uppsala. Randomisation 1:1 and eCRF will be done using RedCap.
Each eligible kidney for the trial will be randomised 1:1 between the following groups:
Group 1 - control group: Following in-situ NRP and in-situ flushing, the kidney will be packed in a storage box and stored on ice until back-table preparation before transplantation at the recipient centre.
Group 2 - intervention group: Following in-situ NRP and in-situ flushing, the kidney will be placed on the Kidney Assist Transporter HMPO2 device and perfused with oxygenated Belzers Machine Preservation Solution at a pulsatile pressure of 25 mmHg starting immediately after retrieval until back-table preparation before kidney transplantation at the transplant centre. Oxygen will be delivered at a rate of 100 ml/min via an oxygenator from a portable oxygen cylinder, resulting in a partial oxygen tension in the perfusate of 90 kPa (for reference, +/- 675 mmHg).
Kidney donors All standard allocation rules and recipient matching will be undertaken according to standard practice. Randomisation 1:1 of the kidneys between the two study arms will be done once the recovery of the organs is completed successfully with NRP and both kidneys are accepted for transplant. One kidney will be allocated to static cold storage preservation arm and the other to HMPO2 arm. If both kidneys are transplanted at the same centre, an additional stratification will determine which kidney will be transplanted first. If only one kidney is recovered or allocated to a Swedish centre, this will be randomised following a kidney alone randomisation procedure. Kidneys will be shared between the four transplant centres according to clinical protocols in place. The care of the donor and the NRP recovery procedure, will be performed according to standard practice.
Kidney recipients Written consent regarding trial participation will be sought from all patients on the waiting list or for the newly listed patients, at the time of listing. Kidney recipients will be selected according to national organ allocation rules, independent of participation in the trial. Surgery will be performed according to local clinical protocols and postoperative care managed according to standard of care. During the follow-up, biopsies will be performed according to the local standard of care and if indicated for clinical management. At the end of the one year follow up, a renal biopsy will be taken to determine the iBox score. The clinical care of the patients will reflect the current standard of care at the recipient hospital with no deviation from routine care protocols.
Modifications
Adherence Since the intervention occurs prior to the transplantation procedure, there are no measures to assure adherence to study intervention. For data collection, all variables beside the 1-year study biopsy are part of standard of care after kidney transplantation so no additional measures are needed. As one year biopsy is not part of routine care in all centres, all study participants will be consented for the biopsy and will have the option to opt out. A subgroup analysis will be undertaken in those patients for whom a one year biopsy is undertaken. All study participants that consented to participation, will receive a written invitation for the biopsy performed at the local centre.
Follow up visits All follow-up visits and endpoint measures besides the 1-year biopsy are standard of care after renal transplantation in Sweden. The patient will receive an invitation for the 1-year biopsy if they've signed the informed consent for biopsy. Data will be collected from patient medical records after informed consent. Data will be accessed in medical records.
During the trial the following data will be retrieved:
Variables and data collection Data will be collected on RedCap for the trial. All blood sampling will be undertaken as part of the routine clinical follow-up with additional study specific samples as above.
Recruitment Approximately 100 kidney transplants from DCD donors are performed each year in Sweden. Although these numbers are expected to increase by about 20%-30% over the next 3 years, researchers planned recruitment on the current level of activity and are confident that 107 eligible kidney pair recipients will be recruited in 36 months (allowing for a the drop out in follow-up and for organs allocated in Scandiatransplant in the STAMP exchange and the payback system between countries). The researchers therefore estimate an enrolment of about 214 DCD kidney transplants during the study period.
Study duration The study is planned to start in January 2027 and with patient inclusion between March 2027 and December 2029, with a one year follow until December 2030. Written summary and presentation of findings in peer-reviewed journals is planned to be completed by March 2031.
Karolinska University Hospital is the lead sponsor of 279 studies on the registry; 55 are open to participants now.
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Donor kidneys:
Recipients:
Exclusion Criteria:
Donor kidneys:
1. Kidney allocated outside of Sweden according to Scandiatransplant allocation rules.
Recipients:
DCD kidneys recovered with NRP and undergoing ex situ HMPO2 initiated at donor hospital as the intervention
Device: Ex situ hypothermic oxygenated machine preservation
DCD kidneys recovered with NRP followed by static cold storage
Ex situ preservation of NRP DCD kidneys with hypothermic oxygenated machine perfusion
Renal function after transplantation
Renal function estimated by the glomerular filtration rate at 1 year after transplantation as determined by the Lund Malmö revised formula for eGFR calculated based on creatinine value
Time frame: One year after transplantation
1. the iBox score at one year
iBOX scoring system is an innovative composite endpoint that has been validated by EMEA and FDA as the first surrogate end point for clinical studies. iBox is a risk prediction score that utilises multiple clinical and pathological relevant features (estimated glomerular filtration rate (eGFR), proteinuria, anti-human leukocyte antigen donor-specific antibody, and kidney graft biopsy histopathology) at one-year post-transplant to predict the likelihood of the transplanted kidney to fail over fixed intervals (3, 5, and 7 years). The output is presented as a continuous mathematical percentage and the score is interpreted as the absolute statistical risk of losing the kidney graft.
Time frame: One year after transplantation
Graft (uncensored and censored for recipient death) survival
Survival rate of kidney transplant
Time frame: One year after transplant
Patient survival
Proportion of patient survivint
Time frame: One year after transplantation
Delayed graft function
Need for dialysis for all causes within the first 7 days after kidney transplantation.
Time frame: 7 days after transplantation
Postoperative complications
Post operative complications measured by the comprehensive complication index (CCI). CCI ranges from 0 to 100, with higher scores reflecting higher number and more severe complications
Time frame: Three months and one year after transplant
Incidence of acute rejection
The proportion of patients having biopsy proven acute rejection episodes
Time frame: One year after transplantation
Health economic analysis
Health economic analysis and cost effectiveness analysis of using ex situ oxygenated machine perfusion in addition to NRP in DCD kidney transplantation
Time frame: One year post transplantation
Kidney Disease Quality of Life (KDQOL)
Recipient health related quality of life post transplantation measured specifically for individuals with chronic kidney disease. Range 0-100 with higher values reflecting better quality of life.
Time frame: Three months and one year after transplantation
Kidney transplant questionnaire KTQ-25
Evaluates the health related quality of life specifically in patients who have undergone a kidney transplant on a 7 point Likert scale with lower score reflecting a worse state.
Time frame: Three months and one year post transplant
EQ-5D-5L
A measure of generic health related quality of life and health status with three dimensions: * health state profile (range from 11111 -perfect health to 55555 worst health) * utility score (with a score of 1 representing perfect health and a score of 0 representing a health state equivalent to death) * visual analogue score ranging from 0 -worst health to 100 - best health
Time frame: Three months and one year post transplant.
36-Item Short Form Health Survey (SF-36)
Patient reported health-related quality of life measured on a 0-100 scale where 100 represents the best status and 0 the worst status.
Time frame: Three months and one year post transplant
Biomarkers of kidney injury
We will also measure various biomarkers of kidney injury and inflammation in perfusate, tissue, and blood samples, including lactate dehydrogenase, D-dimer, cardiolipin, Neutrophil Gelatinase-Associated Lipocalin, Kidney Injury Molecule-1, Glutathione S-transferase, interleukin-18, fatty acid binding protein, and microRNA 21 and proteomic analyses.
Time frame: One year post transplantation
Donor derived cell free DNA
Quantification of kidney injury post transplant measured as absolute quantification and fractional abundance
Time frame: 6, 12, 24, 48, 72 hours; 1 and 2 weeks; and 1, 3, 6, 12 months after transplantation
D-dimers
Measures the risk of microthrombosis in the kidney transplant with higher levels indicating micro thrombosis of the kidney.
Time frame: 6, 12, 24, 48, 72 hours; 1 and 2 weeks; and 1, 3, 6, 12 months after transplantation
Neutrophil Gelatinase-Associated Lipocalin (NGAL)
Measures the level of acute kidney injury with higher level denoting more sever injuries.
Time frame: 6, 12, 24, 48, 72 hours; 1 and 2 weeks; and 1, 3, 6, 12 months after transplantation
cardiolipin antibodies
Measures the risk of vascular complications and early graft failure with higher level denoting increased risk of transplant failure.
Time frame: 6, 12, 24, 48, 72 hours; 1 and 2 weeks; and 1, 3, 6, 12 months after transplantation
Kidney Injury Molecule-1 (KIM-1)
Non invasive biomarker of early proximal tubular injury with level and risk of DGF and acute rejection
Time frame: 6, 12, 24, 48, 72 hours; 1 and 2 weeks; and 1, 3, 6, 12 months after transplantation
Glutathione S-Transferase (GST)
Biomaker of kidney injury measuring the level of cellular damage in the kidney transplant with higher levels suggesting a greater degree of damage
Time frame: 6, 12, 24, 48, 72 hours; 1 and 2 weeks; and 1, 3, 6, 12 months after transplantation
Interleukin-18 (IL-18)
Biomarker measured in the urine to identify acute ischemic and inflammatory injuries with higher levels indicating greater damage.
Time frame: 6, 12, 24, 48, 72 hours; 1 and 2 weeks; and 1, 3, 6, 12 months after transplantation
Liver-type Fatty Acid-Binding Protein (L-FABP)
Non-invasive urine biomarker used to detect allograft ischemia and oxidative stress
Time frame: 6, 12, 24, 48, 72 hours; 1 and 2 weeks; and 1, 3, 6, 12 months after transplantation
microRNA-21 (miR-21)
Non-invasive genetic biomarker to predict delayed graft function and monitor the progression of chronic tissue scarring.
Time frame: 6, 12, 24, 48, 72 hours; 1 and 2 weeks; and 1, 3, 6, 12 months after transplantation
Urinary proteome analysis
Cutting-edge diagnostic tool in kidney transplantation \[1\]. Instead of tracking a single protein, it measures patterns of hundreds of distinct protein fragments simultaneously to detect early allograft rejection and predict long-term organ survival.
Time frame: 6, 12, 24, 48, 72 hours; 1 and 2 weeks; and 1, 3, 6, 12 months after transplantation
Plan to share: No
Start is estimated for Jan 2027; primary completion for Dec 2030, 47 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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